Quality Systems

Chris Spivey is the editorial director of 

Podcasts

In this episode of the Drug Solutions Podcast, Chris Spivey, editorial director, interviews Michael Kopcha, Sau Lee, and Cindy Buhse of FDA about not being afraid to try new approaches and how they invite fresh ideas and abundant communication.

Drug Solutions Podcast: FDA Weighs in on Advancing the Science of Pharmaceutical Manufacturing

Articles

The draft guidance describes the benefit-risk principles used to conduct product quality-related assessments of CMC information submitted to FDA for assessment as part of NDAs, BLAs, or supplements.

FDA Publishes Draft Guidance on Quality Assessments

Feliza Mirasol is the science editor for 

Editor of Pharmaceutical Technology Europe

Videos

In this episode of Drug Digest, Pharmaceutical Technology editors, Felicity Thomas and Feliza Mirasol, examine the topic of emerging therapies in more detail, covering subjects such as the challenges of scale, the potential benefits of drug delivery innovation, importance of early analytical studies, the evolution of the regulatory landscape, and differences between regional regulatory requirements.

Drug Digest: Emerging Therapies in All Shapes and Sizes

Marwan Alsarraj is the Biopharma Segment manager at Bio-Rad.

Using more exacting analytical tools can give a clearer assessment of gene-editing outcomes.

Assessing the Success of CRISPR Gene Therapies Using ddPCR

Susan Haigney is managing editor of BioPharm International, susan.haigney@ubm.com.

Establishing a quality culture from the top of an organization down to each and every employee ensures a safe and effective product, and saves costs.

A Robust Quality Culture Benefits All

Renato Rjavec is director of product management at Amplexor Life Sciences.

The move toward using the Digital Application Dataset Integration (DADI) project for the initial implementation of IDMP-based regulatory data submissions offers both opportunities and challenges for pharmaceutical organizations.

What DADI Means for the Pharmaceutical Industry

Siegfried Schmitt, PhD, is Vice President Technical at Parexel International, Siegfried.Schmitt@parexel.com.

Process validation for a drug product must be done with commercial scale batches, says Siegfried Schmitt, vice president, Technical at Parexel.


Which Batch Size for Validation and Stability Studies?

Pfizer has issued a voluntary nationwide recall of lots of Accupril due to N-nitroso-quinapril content.

Pfizer Issues Voluntary Nationwide Recall of Lots of Accupril

Mylan Pharmaceuticals is issuing a voluntary recall of one batch of insulin glargine injection due to the potential for a missing label in the batch.

Mylan Pharmaceuticals Issues Voluntary Recall of Insulin Glargine Injection

Hallie Forcinio is packing editor for Pharmaceutical Technology and Pharmaceutical Technology Europe, editorhal@sbcglobal.net.

Exhibitors display primary packaging, secondary packaging, and machine innovations at this year’s INTERPHEX. 

Quality Assurance/Quality Control